Drs. Pharmacy Triple Antibiotic Plus: Package Insert and Label Information

DRS. PHARMACY TRIPLE ANTIBIOTIC PLUS- pramoxine hydrochloride, bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
OL PHARMA TECH, LLC Drs PHARMACY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Bacitracin zinc 400 units
Neomycin 3.5 mg
Polymyxin B sulfate 5,000 units

Pramoxine hydrochloride 10 mg

Uses

first aid to help prevent infection in minor
• cuts
• scrapes
• burns

Purpose

  • first aid antibiotic
  • External Analgesic

Do Not Use

Do not use
• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor

For external use only

Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if
• the condition persists or gets worse
• a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• clean the affected area
• apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
• may be covered with a sterile bandage

OTHER INFORMATION

Store at room temperature

Inactive Ingredient

Petrolatum

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drs. Triple Antibiotic Plus
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DRS. PHARMACY TRIPLE ANTIBIOTIC PLUS
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80489-757
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1000 mg
BACITRACIN ZINC (BACITRACIN) BACITRACIN 400 [USP’U] in 1000 mg
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1000 mg
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 [USP’U] in 1000 mg
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80489-757-01 1 TUBE in 1 CARTON contains a TUBE
1 14000 mg in 1 TUBE This package is contained within the CARTON (80489-757-01)
2 NDC:80489-757-02 1 TUBE in 1 CARTON contains a TUBE
2 28300 mg in 1 TUBE This package is contained within the CARTON (80489-757-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 09/05/2021
Labeler — OL PHARMA TECH, LLC Drs PHARMACY (021170377)
Registrant — OL PHARMA TECH, LLC Drs PHARMACY (021170377)
Establishment
Name Address ID/FEI Operations
OL PHARMA TECH, LLC Drs PHARMACY 021170377 manufacture (80489-757)

Revised: 09/2021 OL PHARMA TECH, LLC Drs PHARMACY

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